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| Sponsors and Collaborators: |
Ottawa Health Research Institute Canadian Institutes of Health Research (CIHR) Canadian Diabetes Association |
|---|---|
| Information provided by: | Ottawa Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00195858 |
Purpose
The purpose of this study is to evaluate the effects of resistance training, aerobic training, and combined aerobic and resistance training on percent body fat, measured using Magnetic Resonance Imaging (MRI), in sedentary post-pubertal overweight or obese youth aged 14-18 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: aerobic and resistance exercise |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY) Trial |
| Estimated Enrollment: | 340 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Background: Obesity and inactivity independently increase risks of chronic disease in adolescence and all-cause mortality in adulthood. In clinical trials, changes in exercise and diet can reduce adiposity and risk of diabetes and other chronic diseases in obese adults and youth. In many school systems, physical education is mandatory in elementary school but not high school, and physical activity often declines during adolescence. Because physical activity habits track from adolescence to adulthood, adolescence may represent a critical period for establishing a physically active lifestyle to prevent diseases associated with inactivity in adulthood. Obesity can make adherence to aerobic activity challenging, but would present less of an obstacle to resistance training. Resistance exercise has shown favorable effects on lean body mass, metabolic rate, insulin resistance, and quality of life in adults, but almost no research has examined effects of resistance training in obese adolescents. Our own survey in a sample of obese, primarily sedentary youth found greater overall interest in resistance exercise than aerobic exercise.
Objectives: The primary objective of this study is to evaluate the effects of resistance training, aerobic training, and combined aerobic and resistance training on percent body fat measured using Magnetic Resonance Imaging (MRI) in sedentary post-pubertal overweight or obese youth aged 14-18 years.
Study Design: Randomized controlled trial conducted at a single site. After a 4-week supervised low-intensity exercise run-in period to test compliance, 292 adolescents with BMI ≥ 85th percentile for age and gender will be randomized in equal numbers to one of 4 arms: Diet + aerobic exercise, diet + resistance exercise, diet + combined aerobic and resistance exercise, or diet-only control. The intervention will last 22 weeks, with a follow-up assessment at 6-months post-treatment (11-months post-randomization).
Hypotheses: Reduction in percent body fat will be larger in diet + aerobic exercise and diet + resistance exercise than diet-only controls at post-treatment, and the combined aerobic and resistance training will be superior to either aerobic or resistance training alone in reducing percent body fat at post-treatment. The combined resistance and aerobic group will show greater improvements in percent body fat, body composition, and physiological and psychosocial function at post-treatment and 12-months follow-up. Groups that include resistance training will produce greater psychosocial changes and better adherence than aerobic training alone at post-treatment and follow-up.
Significance: The global burden of obesity in youth is increasing, and more effective intervention is needed. This study may identify that resistance training is an important component in the treatment of overweight adolescents. As such, findings may influence clinical decision making in the management of juvenile obesity, as well as inform public health exercise guidelines and school-based physical education curricula in attempt to reduce the economic, medical, and psychosocial burden of obesity in youth.
Eligibility| Ages Eligible for Study: | 14 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Penny A Phillips, BSc., MA | 613-738-8400 ext 81959 | pphillips@ohri.ca |
| Canada, Ontario | |
| Ottawa Health Research Institute | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Contact: Penny A Phillips, BSc.,MA 613-738-8400 ext 81959 pphillips@ohri.ca | |
| Contact: Elaine Parker 613-798-5555 ext 17631 eparker@ohri.ca | |
| Principal Investigator: Ronald J Sigal, MD MPH FRCPC | |
| Principal Investigator: Stasia Hadjiyannakis, MD | |
| Principal Investigator: Glen Kenny, PHD | |
| Principal Investigator: Gary Goldfield, PHD | |
| Principal Investigator: | Ronald J Sigal, MD MPH FRCPC | Ottawa Health Research Institute, University of Ottawa and the Ottawa Hospital |
More Information
| Responsible Party: | OHRI ( R. Sigal ) |
| Study ID Numbers: | MCT-71979 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00195858 |
| Health Authority: | Canada: Health Canada |
|
Youth Exercise Physical Activity Aerobic Resistance |
Overweight obese Canada Sigal |
|
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overnutrition Overweight Healthy |
